What are the responsibilities and job description for the Clinical Trial Assistant position at Meet Life Sciences?
Job Summary :
We are seeking a detail-oriented, highly organized Clinical Trial Assistant (CTA) to join our Clinical Operations team. The CTA will provide critical administrative and operational support for the successful execution of clinical trials. This position involves close collaboration with cross-functional teams, ensuring smooth trial management, compliance with regulatory requirements, and timely project progression.
Key Responsibilities :
- Trial Coordination & Support :
- Assist in the preparation, initiation, and monitoring of clinical trial activities.
- Coordinate the setup of clinical trial sites, including reviewing and processing documents such as site contracts, ethics committee approvals, and investigator brochures.
- Track and manage trial documentation, ensuring completeness and compliance with applicable regulations and company standards.
- Data & Document Management :
- Maintain accurate and up-to-date trial documentation in accordance with Good Clinical Practice (GCP), regulatory requirements, and internal SOPs.
- Support the collection, filing, and tracking of essential documents such as regulatory submissions, patient consent forms, and source documents.
- Assist in the preparation and submission of regulatory documentation for site initiation, amendments, and close-out activities.
- Study Logistics & Scheduling :
- Coordinate and schedule site visits, investigator meetings, and other key study-related events.
- Ensure study materials (e.g., investigational products, study supplies) are delivered to trial sites on time.
- Track study timelines, milestones, and deliverables, supporting project teams to ensure adherence to timelines.
- Communication & Liaison :
- Serve as a key point of contact between the clinical trial team, investigators, and external vendors.
- Assist in managing communication with sites, vendors, and internal stakeholders, addressing inquiries and facilitating efficient problem-solving.
- Compliance & Reporting :
- Support clinical trial managers with the preparation of study reports and documentation for regulatory audits and inspections.
- Maintain tracking systems for adverse events, protocol deviations, and other key study metrics.
